Hamra Blue, 0.40% W/W Teat Dip Or Teat Spray Solution
Revised: May 2014
AN: 00051/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hamra Blue, 0.40% w/w Teat Dip or Teat Spray Solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Qualitative composition Active substance Chlorhexidine digluconate Excipients Contains Patent Blue V (E 131) |
Quantitative composition 0.41% w/v = 0.40% w/w (as chlorhexidine digluconate 20% w/v solution). 0.0002 % w/v. |
For a full list of excipients, see Section 6.1.
PHARMACEUTICAL FORM
Teat dip / teat spray solution.
Clear blue liquid.
CLINICAL PARTICULARS
Target species
Lactating dairy cattle
Indications for use, specifying the target species
Teat disinfectant (dip or spray), prophylactic (as an aid in the prevention of mastitis in lactating dairy cattle).
Contraindications
None.
Special warnings for each target species
Wash and dry udder and teats before milking.
For external use only.
Teat dip cups should be emptied after milking and washed before re-use.
If signs of disease persist or appear, consult your veterinary surgeon.
Special precautions for use
Special precautions for use in animals
None.
Special precautions for the person administering the veterinary medicinal product to animals
Care should be taken to reduce the possibility for eye contact. In case of eye contact, flush the eyes with copious amounts of water and seek medical advice.
In case of ingestion, drink large quantities of water and obtain medical attention as soon as possible.
When used as a spray, avoid working in a spray mist.
Wash hands after use.
Other precautions
None.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
For use during lactation.
Interaction with other medicinal products and other forms of interaction
Not to be used concurrently with soaps and anionic substances.
Amount to be administered and administration route
Use undiluted immediately after milking.
Fill cup three quarters full and dip each teat full length immediately after each milking, or spray entire surface of each teat after milking.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period
Meat / milk: zero days / hours
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiseptics and disinfectants
ATCVet Code: QD08AC02
Pharmacodynamic properties
Hamra blue is an antiseptic. The active ingredient is chlorhexidine digluconate, which is a bisbiguanide antiseptic and disinfectant effective against a wide range of bacteria, some fungi and some viruses. Emollients are present to aid in protecting teats against sores and cracks.
Pharmacokinetic particulars
Not applicable (topical disinfectant).
PHARMACEUTICAL PARTICULARS
List of excipients
Patent Blue V (E131)
Glycerol
Sorbitol Liquid (Non-crystallising)
Isopropyl Alcohol
Alcohol 8 Mole ethoxylate
Simeticone
Citric acid monohydrate
Sodium hydroxide
Water Purified
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Special precautions for storage
Store upright in tightly closed original container.
Do not store above 25°C.
Store in a dry place.
Protect from direct sunlight.
Do not freeze.
Store away from food, drink & animal feedstuffs.
Do not mix with other chemicals.
Used cans should not be recycled.
Nature and composition of immediate packaging
20 litre and 200 litre pigmented high density polyethylene drums with high density polyethylene screw-fit caps.
Screw-caps: Blue (20L)
White (200L)
Seals: Blue (20L)
Red (200L)
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Do not contaminate ponds, waterways or ditches with product or empty container.
MARKETING AUTHORISATION HOLDER
DeLaval NV
Industriepark-Drongen 10
B-9031 Gent
Belgium
MARKETING AUTHORISATION NUMBER
Vm:17140/4005
DATE OF FIRST AUTHORISATION
Date:13 July 1992
DATE OF REVISION OF THE TEXT
Date: May 2014
03 June 2014
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